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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
510(k) Number K250451
Device Name NeurAxis IB-Stim (01-1020)
Applicant
Neuraxis
11611 N. Meridian St.
Suite 330
Carmel,  IN  46032
Applicant Contact Thomas Carrico
Correspondent
MRC Global, LLC
9085 E. Mineral Cir
Suite 110
Centennial,  CO  80112
Correspondent Contact Dawn Norman
Regulation Number876.5340
Classification Product Code
QHH  
Date Received02/18/2025
Decision Date 05/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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